OnabotulinumtoxinA for Trigeminal Neuralgia

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06216886
Phase
PHASE4
Status
Recruiting
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Conditions

  • Trigeminal Neuralgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OnabotulinumtoxinA 100 UNT [Botox] — DRUG
    Intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of onabotA. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.
  • Sodium Chloride 0.9% for Injection, Preservative Free — DRUG
    intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of saline. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.

Study Details

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

Key Dates

Start date
Jun 1, 2024
Status verified
Jan 2026
Primary completion
Feb 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OnabotulinumtoxinA
    Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.
  • Placebo Comparator: Saline
    The same procedure will be followed as above, but saline will be injected instead of onabotA

Primary Outcome Measure

Change in Number of TN Attacks per week [ Time Frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Meredith BaradStanfordCalifornia94304
Meredith Study Team
[email protected]
650-721-7218
Meredith Barad, MD (PRINCIPAL_INVESTIGATOR)

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Meredith Barad· Stanford, CA

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